Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: ARTISS
Active Ingredients: Aprotinin 2250kIU/mL - 3750kIU/mL
Fibrinogen 72mg/mL - 100mg/mL
Dosage Form: Syringe 1 Topical solution
Active Ingredients: Calcium chloride dihydrate 0.036mmol/mL - 0.044mmol/mL
Thrombin 2.5IU/mL - 6.5IU/mL
Dosage Form: Syringe 2 Topical solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Product: Oxybutynin ADE 2.5
Active Ingredient: Oxybutynin hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Farmaceutisch Analytisch Laboratorium Duiven B.V., Duiven, The Netherlands
Product: Oxybutynin ADE 5
Active Ingredient: Oxybutynin hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Farmaceutisch Analytisch Laboratorium Duiven B.V., Duiven, The Netherlands
Product: Pantoprazole
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to pantoprazole base 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Dated this 8th day of March 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).